Product Development Engineer, Lombard Medical Technologies, Irvine CA
Contact Information: Email: RDJobs_at_lombardmedical.com
Basic Requirements:
* Education: B.S. or M.S. in Mechanical or Bioengineering
degree or related field with relevant engineering education and/or
device development experience
* Experience: 1-5+ with B.S., 1-3+ with MS, years of
relevant medical device development experience, depending
capabilities, relevant skills and educational background
* Travel: <25%
Position Description:
Innovate and develop new and improved minimally invasive and
endovascular technologies including stent-grafts and delivery systems
for treating aortic disorders.
Responsibilities:
* Work with the team and more senior engineers to conduct
the following deliverables
* Collaborate with physicians to establish customer needs
and translate them into appropriate design intent and engineering
requirements that can be effectively developed
* Design, development and testing of new concepts and
products and tooling from concept to product commercialization
* Conduct verification and validation testing and create
respective documentations
* Work and collaborate with external suppliers and vendors
* Perform design and process risk analyses (dFMEA and pFMEA)
* Work with cross-functional teams
* Support design control deliverables and regulatory
submissions necessary for successful commercialization of products
Qualifications:
* Good science and engineering fundamentals in device
development, mechanical and structural design, material science,
fluid dynamics and problem-solving methodologies.
* Strong technical skills and engineering tools such as
CAD, FEA, Matlab, Minitab, statistical methods, equipment/fixture
development, injection molding and other medical device development skills
* Good organizational and planning skills
* Testing and test method development applying good lab practices
* Verification and validation testing and documentation
(lab notebook, protocols and reports)
* Experience and knowledge in medical device design
control deliverables, quality system regulations, regulatory
requirements and manufacturing practices (GMP, GLP, CAPA, ISO
standards, FDA regulations)
* Computer skills: Microsoft office applications and
programming skills (C++, Java, etc.)
* Ability to work in a team environment effectively
* Good verbal and written communication skills
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Potential applicants should communicate directly with the contact
listed in the posting. Please do not "reply" to the posting messages.
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Received on 2015-03-08 16:51:42